BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX EX IMPLANT 4.0X9

    MDR report key: 7499196 · Received May 9, 2018

    Report

    Report Number
    3008261720-2018-02109
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    March 29, 2018
    Report Date
    May 9, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568843
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS USED SEQUENCE OF DRILLS DIFFERENT THAN THE ONES RECOMMENDED FOR THE IMPLANT INSTALLATION. AFTER THE EVALUATION WAS NOTICED THAT THE ITEM RECEIVED IS DIFFERENT FROM THE ITEM REPORTED ON GUARANTEE FORM BY THE DENTIST. THEREFORE, THE LOT NUMBER WAS NOT CONSIDERED.

    Description of Event or Problem · 0

    RP 011812 - THE DENTIST REPORTED THAT AFTER 1 MONTH DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 20#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 30NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341034 CM TITAMAX EX IMPLANT 4.0X9 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237568843

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention